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Monday, June 17 • 11:00am - 12:00pm
#114: Breaking Boundaries: Overcoming Policy Crosstalk and Globalization Barriers to Foster Innovation

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-528-L04-P; CME 1.00; RN 1.00

We all want to see innovation in treatments and prevention that meets the many unmet needs of patients globally. And yet, despite this compelling goal, the complexity and uncertainty involved in delivering innovation has baffled policy makers, regulators, healthcare systems and companies at every step of the process. The response has been to establish policies and requirements to “direct” innovation to best effect. The result has been a confused environment where crosstalk of policy measures and requirements collectively and often constrain, rather than enable, innovation.

In this forum, we are going to aim to take a more holistic framing of the drive for innovation and explore three recent cases where policy crosstalk risks frustrating innovation.

Learning Objectives

Explore how various legislative and other policy-related initiatives, including some not directly targeting the industry, are threatening the climate for development of innovative products.

Chair

Virginia Acha, PhD, MSc

Speaker

Policy Cross-Talk Case Study: Clinical Research
Karen A Noonan, MA

Policy Cross-Talk Case Study: Supply Chains and Resilience
Christopher Colwell, MPA

Policy Cross-Talk Case Study: Pricing and Access Policies
Duane Schulthess, MBA


Speakers
avatar for Virginia Acha

Virginia Acha

AVP, Global Regulatory Policy, Merck & Co, United States
Virginia (Ginny) has worked in industry and academia throughout her career, combining interests in science policy research and innovation performance within and across organizations. She joined MSD in 2017 to lead regulatory policy efforts ex-US for innovation that leads to better... Read More →
CC

Christopher Colwell

Vice President, International Government and Regulatory Affairs, US Pharmacopeia, United States
Chris Colwell is Vice President, International Government & Regulatory Affairs at the United States Pharmacopeia (USP). He leads a team that develops USP’s position on public policy and regulatory affairs issues related to its mission to improve global health through public standards.Chris... Read More →
avatar for Karen Noonan

Karen Noonan

Senior Vice President, Global Regulatory Policy, Association of Clinical Research Organizations (ACRO), United States
Karen joined the Association of Clinical Research Organizations (ACRO) in 2014. Founded in 2002, ACRO represents the world’s leading clinical research and technology organizations. In her role as Senior Vice President of Global Regulatory Policy, she leads ACRO’s global regulatory... Read More →
avatar for Duane Schulthess

Duane Schulthess

Chief Executive Officer, Vital Transformation LLC, United States
Duane Schulthess is the CEO of Vital Transformation, an economics consultancy in Brussels, Belgium and Washington, DC. He is a member of the U.S. Congressional Health Care Task Force, and the Executive Producer of the Vital Health Podcast, ranked in the top 30 healthcare podcasts... Read More →

Monday June 17, 2024 11:00am - 12:00pm PDT
Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  12: Value-Access, Forum